CDC, WHO, and Biotech Companies: The Critical Need for Quicker Coronavirus Testing

The CDC (Center for Disease Control and Prevention), WHO (World Health Organization), and commercial laboratories are in a quandary. The first COVID-19 case in the US occurred on January 21, but after eight weeks, the country still lacked diagnosis test kits for the people who needed them. According to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, the system in place is admittedly not geared to respond to the needs of the current situation properly. Daily testing in the US is limited to roughly 7,000 only.

PCR (or polymerase chain reaction) analysis is a tried and tested in detecting parts of the genetic material of a virus from tissue samples. It is reliable, highly sensitive, and fairly accurate. However, in a pandemic such as the COVID-19 that has alarming severity and spread, critics say it's simply too slow.

According to Boston University Laboratory for Diagnostics and Global Healthcare Technologies director Catherine Klapperich, tests in this situation need to be quicker, and the technology exists but has not been commercialized so that it is not readily available. She adds that such a quick method of testing for the presence of a virus is known as point-of-care testing, and is essential in an outbreak.

The Sars-CoV-2 or the novel coronavirus' genetic sequence, which is necessary for making a PCR test, was already known last January. Researchers in Germany designed such test, and WHO or the World Health Organization used this.

PCR testing is cheap and straightforward but complicated. Klapperich explained, not all laboratories are capable of doing it, and the entire procedure takes hours. Plus, special permits must be acquired by laboratories to do it, which can take months.

The German test was the one used by different countries. South Korea tests about 10,000 people daily and has so far completed 250,000 tests. It was able to do testing faster because it did not have as many legal constraints as the U.S. had.

CDC did not use this protocol and developed and used its own test. However, it yielded results that were false positive and was quickly recognized as unworkable. CDC thus had to design and produce new test kits, adding to more delays in the crucial race to test more people at the soonest possible time.

The slow approval process for new tests by the FDA or Food and Drug Administration was another cause for delay. To speed up the process, it relaxed its rules for approval and allowed commercial laboratories to start testing for the virus on February 29. Roche, a diagnostics and pharmaceutical company, only got support for automated testing last March 13.

Speed is of the essence in a pandemic. This is also evident in the effects of the different reactions to the 2009 H1N1 pandemic compared to today's COVID-19. An ideal test would have a result after only 20 minutes. Tests that look for proteins on virus surfaces instead of viral genes are faster, but they are less sensitive and are much more susceptible to false-negative results.